Pulmonary VentilationNCT03822689
Comparison of Ventilation Tubes Among Anesthetized Pediatrics
A study testing Ventilator breathing tube F2220, Ventilator breathing tube F2216 and Ventilator breathing tube F1520 in people with Pulmonary Ventilation, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
To discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Ventilation
- What is being tested?
- Ventilator breathing tube F2220, Ventilator breathing tube F2216 and Ventilator breathing tube F1520
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- with American Society of Anesthesiologists (ASA) physical status classification 1\&2
- undergo elective surgery
- intubation
Who cannot join
- Cardiac-pulmonary surgery
- Had respiratory related disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
To discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. The study compares eight ventilator breathing tube of different length, diameter, material of the ventilator breathing tube. Besides, the investigators also make an approach verify the change of body temperate under different gas flow(2L, and 5L).
Read the detailed description
In previous research, initial mechanical ventilator settings about children were as following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of respiratory pressure should be <10 cmH2O in healthy patients; 3. respiratory pressures could be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory pressure was necessary, although the optimal level is unknown.
However, few researches discussed about Influences of different types of ventilation breathing tube. The investigators want to clarify the character about length, diameter, and material of the ventilation breathing tube under the ventilation system in relation to tidal volume, end tidal carbon dioxide, compliance among children and neonate.
During this study, the participants will be 100 children who were ASA class1, 2 and performed non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants will divide into three groups according to different body weights (Group N: <4.5kg; Group T: 4.5~20kg; Group C: >20kg), and would receipt total eight type of ventilator breathing tube test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and compliance. Besides, secondary outcome will be the change of body temperate under different gas flow (2L, and 5L).
- Conditions
- Pulmonary Ventilation
- Being tested
- Ventilator breathing tube F2220, Ventilator breathing tube F2216, Ventilator breathing tube F1520, Ventilator breathing tube F1516, Ventilator breathing tube U1016
- Keywords
- pediatric, Ventilation breathing tube, End-Tidal Carbon Dioxide, Heart rate, tidal volume, blood temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator breathing tube F2220Device
M: Folding D: 22mm; L: 2.0M
Ventilator breathing tube F2216Device
M: Folding; D: 22mm; L:1.6M
Ventilator breathing tube F1520Device
M: Folding; D: 15mm; L:2.0M
Ventilator breathing tube F1516Device
M: Folding; D: 15mm; L:1.6M
Ventilator breathing tube U1016Device
M: Unfolding; D: 10mm; L:1.6M
Ventilator breathing tube U1516Device
M: Unfolding; D: 15mm; L:1.6M
Ventilator breathing tube CA20Device
M: Co-axis; L:2.0M
Ventilator breathing tube CA16Device
M: Co-axis; L:1.6M
| Study group | Role | What they receive |
|---|---|---|
| Gas flow:2L | Active comparator | use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M Receives: Device: Ventilator breathing tube F2220; Device: Ventilator breathing tube F2216; Device: Ventilator breathing tube F1520; Device: Ventilator breathing tube F1516; Device: Ventilator breathing tube U1016; Device: Ventilator breathing tube U1516; Device: Ventilator breathing tube CA20; Device: Ventilator breathing tube CA16 |
| Gas flow:5L | Active comparator | use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M Receives: Device: Ventilator breathing tube F2220; Device: Ventilator breathing tube F2216; Device: Ventilator breathing tube F1520; Device: Ventilator breathing tube F1516; Device: Ventilator breathing tube U1016; Device: Ventilator breathing tube U1516; Device: Ventilator breathing tube CA20; Device: Ventilator breathing tube CA16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
compared tidal volume besides different ventilation breathing tube
Measured: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
End tidal carbon dioxide
compared End tidal carbon dioxide besides different ventilation breathing tube
Measured: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
Secondary outcomes (1)
Body temperate
compared Body temperate about different gas flow(2L,5L)
Measured: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: Institutional Review Board did not approve
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chien-Chung Huang, MD, Study director, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822689
- Sponsor's protocol ID
- 19MMHIS025e
- Status last verified
- Jun 2020
- First submitted
- 25 Jan 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.
PubMed 25625261Kneyber MC. Intraoperative mechanical ventilation for the pediatric patient. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):371-9. doi: 10.1016/j.bpa.2015.10.001. Epub 2015 Oct 14.
PubMed 26643101Glenski TA, Diehl C, Clopton RG, Friesen RH. Breathing circuit compliance and accuracy of displayed tidal volume during pressure-controlled ventilation of infants: A quality improvement project. Paediatr Anaesth. 2017 Sep;27(9):935-941. doi: 10.1111/pan.13164. Epub 2017 May 15.
PubMed 28504341von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.
PubMed 15673856
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03822689
- Acronym / sponsor ID
- 19MMHIS025e
- Conditions
- Pulmonary Ventilation
- Keywords
- pediatric, Ventilation breathing tube, End-Tidal Carbon Dioxide, Heart rate, tidal volume, blood temperature
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional Review Board did not approve
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. The study compares eight ventilator breathing tube of different length, diameter, material of the ventilator breathing tube. Besides, the investigators also make an approach verify the change of body temperate under different gas flow(2L, and 5L).
Detailed description
In previous research, initial mechanical ventilator settings about children were as following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of respiratory pressure should be <10 cmH2O in healthy patients; 3. respiratory pressures could be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory pressure was necessary, although the optimal level is unknown.
However, few researches discussed about Influences of different types of ventilation breathing tube. The investigators want to clarify the character about length, diameter, and material of the ventilation breathing tube under the ventilation system in relation to tidal volume, end tidal carbon dioxide, compliance among children and neonate.
During this study, the participants will be 100 children who were ASA class1, 2 and performed non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants will divide into three groups according to different body weights (Group N: <4.5kg; Group T: 4.5~20kg; Group C: >20kg), and would receipt total eight type of ventilator breathing tube test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and compliance. Besides, secondary outcome will be the change of body temperate under different gas flow (2L, and 5L).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gas flow:2L | Active comparator | Device: Ventilator breathing tube F2220, Device: Ventilator breathing tube F2216, Device: Ventilator breathing tube F1520, Device: Ventilator breathing tube F1516, Device: Ventilator breathing tube U1016, Device: Ventilator breathing tube U1516, Device: Ventilator breathing tube CA20, Device: Ventilator breathing tube CA16use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M |
| Gas flow:5L | Active comparator | Device: Ventilator breathing tube F2220, Device: Ventilator breathing tube F2216, Device: Ventilator breathing tube F1520, Device: Ventilator breathing tube F1516, Device: Ventilator breathing tube U1016, Device: Ventilator breathing tube U1516, Device: Ventilator breathing tube CA20, Device: Ventilator breathing tube CA16use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- with American Society of Anesthesiologists (ASA) physical status classification 1\&2
- undergo elective surgery
- intubation
Key exclusion criteria (2 listed)
- Cardiac-pulmonary surgery
- Had respiratory related disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator breathing tube F2220M: Folding D: 22mm; L: 2.0M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube F2216M: Folding; D: 22mm; L:1.6M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube F1520M: Folding; D: 15mm; L:2.0M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube F1516M: Folding; D: 15mm; L:1.6M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube U1016M: Unfolding; D: 10mm; L:1.6M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube U1516M: Unfolding; D: 15mm; L:1.6M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube CA20M: Co-axis; L:2.0M | Device | Gas flow:2L, Gas flow:5L |
| Ventilator breathing tube CA16M: Co-axis; L:1.6M | Device | Gas flow:2L, Gas flow:5L |
Primary outcome
Tidal volume
Time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
compared tidal volume besides different ventilation breathing tube
End tidal carbon dioxide
Time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
compared End tidal carbon dioxide besides different ventilation breathing tube
1 secondary outcome
Body temperate
Time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Background: PubMed 25625261Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.
- Background: PubMed 26643101Kneyber MC. Intraoperative mechanical ventilation for the pediatric patient. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):371-9. doi: 10.1016/j.bpa.2015.10.001. Epub 2015 Oct 14.
- Background: PubMed 28504341Glenski TA, Diehl C, Clopton RG, Friesen RH. Breathing circuit compliance and accuracy of displayed tidal volume during pressure-controlled ventilation of infants: A quality improvement project. Paediatr Anaesth. 2017 Sep;27(9):935-941. doi: 10.1111/pan.13164. Epub 2017 May 15.
- Background: PubMed 15673856von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Chung Huang, MD study director
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator breathing tube F2220, Ventilator breathing tube F2216 and Ventilator breathing tube F1520 in people with Pulmonary Ventilation, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822689, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.